Australian biotech company CSL Limited endured a sharp ~4% decline on Monday, marking its most significant intraday loss in over four months. This descent followed the unpropitious outcome of its Phase 3 AEGIS-II trial, a critical clinical program.
The global trial was devised to assess serum protein CSL112 against a placebo in order to diminish the risk of major adverse cardiovascular events, such as stroke, in patients following a heart attack (acute myocardial infarction).
Regrettably, AEGIS-II did not achieve the primary efficacy goal of MACE reduction at 90 days, as CSL Limited (OTCQX:CMXHF) disclosed. The company also stated that there were no safety or tolerability concerns. Consequently, in the aftermath of this setback, the company has no immediate plans for regulatory submissions.
“AEGIS-II is the most ambitious study in our company’s history, and we are proud of the quality of the study we delivered and the enhanced capabilities we developed to do so,” remarked CSL’s (OTCQX:CSLLY) Head of Research & Development, Bill Mezzanotte.